N/A N=1,899

Exacerbation Risk in Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT05501639 ↗

Enrolled (actual)

1,899

Serious AEs

—

Results posted

Apr 2024

Primary outcome: Primary: Time to First Severe Exacerbation — 43.75; 49.43 Days — p=0.758

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: tiotropium (Drug); long-acting β2-agonists (LABA) (Drug); inhaled corticosteroids (ICS) (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Severe Exacerbation	43.75; 49.43	0.758
SECONDARY Time to First Moderate-or-severe Exacerbation	65.8; 58.88	0.474
SECONDARY Percentage of Patients With Exacerbation	3.8; 3.2; 50.1; 45.3	0.472
SECONDARY Rate of Exacerbation at 6 Months and One Year	3.21; 4.96; 4.46; 4.45	—
SECONDARY Percentage of Patients With Health Care Resource Utilization (HCRU)	7; 9; 1; 1; 23; 21	0.222
SECONDARY Health Care Resource Utilization (HCRU)	0.007; 0.009; 0.001; 0.001; 0.035; 0.032	0.538
SECONDARY Percentage of Patients With Use of Rescue Medications	57; 55	0.378

Summary

The purpose of this study is to conduct a comparative analysis of patients using Tiotropium in combination with Inhaled Corticosteroids (ICS) versus those that use long-acting β2-agonists (LABA) medication in combination with ICS.

Eligibility Criteria

Inclusion Criteria

Patients with least two asthma diagnosis
Patients will be required to be concurrently on inhaled corticosteroids (ICS)+Tiotropium (tio) (specifically Tiotropium Respimat® 1.25 mcg) or ICS/LABA
Patients will be required to have enrollment for at least 6 months prior to ICS+Tio or ICS/LABA use

Exclusion Criteria

Patients with least two diagnosis of chronic obstructive pulmonary disease (COPD) at any time during the study period
Patients less than 12 years of age
Patients on biologics within 6 months prior to ICS+Tio or ICS/LABA use
Patients with prior Tio or ICS/LABA use during the 6-month baseline period
Patients with urinary bladder obstruction, urinary retention, and glaucoma
After the propensity score matching (PSM) process, unmatched patients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05501639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.